Table 3.

User goals

ID	Title	Description	Reference to BPs
UG1	Use of drug synonyms should be encouraged	Retrieval of drug information, by using either the active substance or empirical or commercial name, should be supported	All BPs are relevant but this feature would be especially useful for BP5 and BP6 where complex queries are typically formed
UG2	Graphical components with conceptual hierarchy should be applied	Conceptual levels/hierarchies and concept groupings provided by well-defined encodings (e.g. MedDRA and WHO–ATC levels) could facilitate the formulation of search queries by users in a more succinct way, exploiting the semantics provided by the respective encodings as part of the user interface	All
UG3	Well-defined unambiguous concepts should be used based on widely accepted thesauri, dictionaries and medical ontologies	The use of well-defined terms is expected to enhance the formulation of queries by reducing semantic ambiguity and to improve access to pertinent well-standardized data sources	All BPs are relevant but this feature would be especially useful for BP5 and BP6 where complex queries are formed
UG4	A multitude of data sources should be used, including, but not restricted to, ICSRs	Both well-established sources (i.e. sources widely used in everyday practice) and emerging sources that are being thoroughly researched for their potential merit in drug safety studies should be used	BP2, BP3, BP4, BP5, BP6, BP7
UG5	Statistical evaluation of potential signals and computational causality assessment	The use of statistical metrics based on disproportionality analysis techniques is the main approach for the detection and ensuing prioritization of potential safety signals and these should be heavily employed	BP3, BP4, BP5, BP7
UG6	Exploit the special characteristics provided by each data source	Each data source provides data of different types with different features, exploitable in terms of drug safety signal investigation. For example, while DA statistics (e.g. PRR, ROR, etc.) might be extremely useful in ICSR databases, these metrics might be irrelevant for social media, and therefore each data source’s special features should be taken into account	BP2, BP3, BP4, BP5, BP7
UG7	Advanced visual analytic features should be integrated	In addition to statistics/numerical data, visual aids could facilitate the in-depth investigation of potential safety signals	BP2, BP3, BP4
UG8	Long term/‘pausable’ processes for investigating a drug safety signal should be available	A ‘save for now and resume later’ feature is critical because such processes are time-consuming and laborious. Especially in the clinical environment where PV is not the top priority of HCPs, such a feature would be of the highest importance	BP2, BP3, BP4, BP5, BP6, BP7
UG9	Capability for long-term monitoring of a signal should be provided	Many safety signals may entail the investigation of longitudinal studies or the long-term monitoring of a drug, and thus they could span long periods of time. By the same token, analysis of clinical trials or the provision of clinical services are also considered lengthy processes	BP3, BP4, BP5, BP6
UG10	Investigation ‘scenarios’ should be identified as the main usage paradigm	Albeit the proven value of direct searches for signal detection, the formulation of investigation scenarios could be even more beneficial due to the deeper analysis of enhanced capabilities that they offer. Notwithstanding, a certain ‘quick search/investigation’ feature can also be included	BP2, BP3, BP4, BP5, BP6, BP7
UG11	Role-based access control for users	This control can enable simultaneous analysis of multiple PV signals. Users can create, edit or delete scenarios, depending on the specific permissions granted to each one of them. Furthermore, collaboration and teamwork can be encouraged and thus mistakes can be prevented	All
UG12	Comprehensive report generation from each investigation scenario	An investigation scenario report would be very useful in order to disseminate the investigation results to other clinical professionals or stakeholders (e.g. regulatory agencies, etc.).	BP2, BP3, BP4, BP5, BP6, BP7
UG13	Access to information for each individual patient case	Due to interpatient variability, the investigation of suspected ADRs demands access to as much detailed information as is available. This could pertain, for example, to the genetic profile of a patient affected by an ADR during clinical trials or to the original form of ICSRs that document a signal	BP2, BP4, BP5, BP7
UG14	Ability to trace back to the original raw data source	Reliability can be assessed or proven only if the exact origin of data can be traced, a feature that might also be important for medical data sharing	BP4, BP5
UG15	User friendliness	Tackling crucial challenges from the clinical setting, such as clinicians’ cramped schedule, or underestimation of PV due to the higher priority of other clinical procedures	All
UG16	Data protection and privacy	Compliance with the regulatory framework and the stringent legalities (e.g. the GDPR)	All
UG17	Extensibility and adaptability	Being versatile with new potential pharmacovigilance data sources and operational in distinct environments (different hospitals, CROs, etc.), irrespective of the computer infrastructure used (e.g. electronic medical record) or the procedures applied	All
UG18	Interoperability	Data generated (e.g. the consolidated reports) must also be computationally exploitable by other information systems	BP2, BP5, BP7

UG user goal, BPs business processes, MedDRA Medical Dictionary for Regulatory Activities, WHO–ATC World Health Organization Anatomical Therapeutic Classification, ICSRs individual case safety reports, DA disproportionality analysis, PRR proportional reporting ratio, ROR reporting odds ratio, PV pharmacovigilance, HCP healthcare professionals, ADR adverse drug reaction, GDPR General Data Protection Regulation